OSI: Tarceva Approved as Maintenance Treatment for Lung Cancer

Finally OSI Pharmaceuticals (OSIP) has reported its expected results from the SATURN study, which confirm that immediate treatment with Tarceva after initial chemotherapy delays the progression of advanced lung cancer and helps patients live longer. Advanced lung cancer has yet to find a satisfactory treatment. It still frustrates oncologists and kills patients with no hope of any rescuing drug.

In the news, OSI Pharmaceuticals and Genentech, announced that SATURN, a pivotal Phase 3 study of Tarceva® (erlotinib), met a key secondary endpoint of ex-tending overall survival in patients with advanced non-small cell lung cancer (NSCLC) who received Tarceva immediately after initial chemotherapy. A statistically significant improvement in overall survival was seen in this pre-planned final analysis of the total patient population.

The new data will be presented during the 13th World Conference on Lung Cancer to be held July 31 to August 4, 2009 in San Francisco.

Treating patients immediately following first-line chemotherapy versus waiting for the cancer to grow or spread before giving additional treatment represents a new approach in advanced NSCLC.

The overall survival data will be submitted to the FDA to support the sNDA for use of Tarceva as a first-line maintenance treatment for patients with advanced NSCLC that was submitted on March 17, 2009.

We hope the drug will be approved in the U.S. around January 2010. Roche will also submit the overall survival data to the European Medicines Agency (EMEA) to support the application for use of Tarceva as a first-line maintenance treatment submitted in March 2009.

Data from SATURN that were presented at the 45th Annual Meeting of the American Society of Clinical Oncology (ASCO) on May 31, 2009 in Orlando, Florida demonstrate that Tarceva had had met its primary endpoint. It showed patients with advanced NSCLC who received Tarceva as a first-line maintenance treatment had a 41 percent improvement in the time they lived without the disease advancing (progression-free survival or PFS) compared to placebo. The safety results were consistent with what has been seen previously and there were no new or unexpected safety signals in the study. The most commonly reported adverse events in patients who received Tarceva were rash (49 percent, 213/438) and diarrhea (20 percent, 88/438).

SATURN is an international, placebo-controlled, randomized, double-blind, Phase 3 study conducted by Roche that enrolled 889 patients with advanced NSCLC at approxi-mately 160 sites worldwide. Patients were treated with four cycles of standard first-line platinum-based chemotherapy and were then randomized to Tarceva or placebo if the cancer did not progress. The primary endpoint of the study was progression-free survival. The co-primary endpoint was PFS in patients with EGFR-positive tumors by IHC. Secondary endpoints included overall survival, safety and an evaluation of exploratory biomarkers, including EGFR mutations and K-ras mutations.

In pancreatic cancer, Tarceva is indicated in combination with gemcitabine for the first-line treatment of patients with locally advanced pancreatic cancer, pancreatic cancer that cannot be surgically removed or pancreatic cancer that has spread to distant body organs.

Great news for oncologists, lung cancer patients and investors who bet on Osi despite the misleading discouraging posted assessments by the firm’s critics or negative investors. We congratulate our subscribers for the great news.

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